• Feature ArticlesFeature Articles

    Excellence and equity: From pilot to program, a Pfizer experience

    In 2021, Pfizer global regulatory affairs colleagues piloted an advanced pharmacy practice experience program as part of a company-wide diversity, inclusion, and equity program in collaboration with Howard University College of Pharmacy (CoP), a US-based historically Black college/university (HBCU). 1 Following pilot success, the initiative was elevated to full program status and the prospective student pool was expanded to include all HBCU CoPs in the US, as well as one ...
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    FINALIST Fostering diversity and talent: A Pfizer case study

    The Pfizer Global Regulatory Affairs (GRA) – Howard University College of Pharmacy (HUCOP) Advanced Pharmacy Practice Experience (APPE) program fulfills a requirement of the Doctor of Pharmacy (PharmD) curriculum and helps students explore biopharmaceutical industry career options and prepare for their career after graduation, such as pursuing postgraduate training and seeking employment. The HUCOP Preceptorship Program at Pfizer was designed to broadly increase awareness ...
  • Regulatory NewsRegulatory News

    FDA approval lowers, but doesn’t eliminate disparities in immunotherapy use

    Racial, ethnic and sociodemographic disparities that are present in clinical trials and compassionate use agreements for cancer immunotherapy during the pre-approval period are reduced, but not eliminated after the US Food and Drug Administration (FDA) approves these cancer treatments, according to recent research published in JAMA Network Open .   “The time frame leading up to FDA approval is an important period in which to observe disparities,” Theresa Ermer, MD, of...
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    Clinical trial diversity: Sponsors seek clarity on data sources, timing

    Drugmakers and clinician organizations praised the US Food and Drug Administration’s (FDA) recent draft guidance containing recommendations on developing a Race and Ethnicity Diversity Plan to improve enrollment of underrepresented racial and ethnic groups in clinical trials. But in public comments, they also called for greater details on the types of data that should be used to assess adequate enrollment of these populations, how these diversity plans should be applied to...
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    January’s Regulatory Focus: Leadership in RA, expanding diversity, and more

    Feature articles during January focused on regulatory leadership, a novel approach to hiring regulatory professionals, expedited programs for reducing time to approval for certain drugs, and the Cuban biotechnology industry and its response to COVID-19. Keywords – assessment aid, breakthrough therapy, Cuba, diversity, ILAP, leadership, PRIME   Leadership, hiring, and expanding diversity Effective leadership in regulatory affairs is rooted in an understanding a...
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    How regulatory affairs can expand its capabilities and increase diversity

    Abstract The recruitment, hiring, and training of regulatory professionals should evolve to attract and retain valuable candidates with diverse perspectives, experiences, and/or skills. Regulatory professionals may consider doing this as part of their diversity, equity, and inclusion (DEI) initiatives by hiring “hidden workers,” a term for multiple groups of people who are chronically unemployed or underemployed because of systemic problems with current workforce trainin...
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    Strengthening the regulatory profession through resilience and diversity

    This article explores the importance of resilience and diversity specific to the regulatory profession in preventing burnout and enhancing overall regulatory capability within an organization. The author addresses existing tools for  functional capability-building and supplemental considerations when intentionally building resilience into regulatory functions.   Introduction Regulatory affairs, or in many cases, a combined functional department named “regulatory an...
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    FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance aimed at increasing diversity in clinical trial populations as part of its efforts to encourage drugmakers to enroll populations that more closely reflect the populations that will take the drugs in the real world.   “This guidance recommends approaches that sponsors of clinical trials to support a new drug application [NDA] or a biologics license application [BLA] can take to broaden eligibi...